ID

43399

Description

ODM derived from http://clinicaltrials.gov/show/NCT00641056

Link

http://clinicaltrials.gov/show/NCT00641056

Keywords

Versions (3)
  1. 12/9/13 12/9/13 - Martin Dugas
  2. 4/15/14 4/15/14 - Julian Varghese
  3. 9/20/21 9/20/21 -
Uploaded on

September 20, 2021

DOI

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License

Creative Commons BY 4.0
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Eligibility NCT00641056 Type 2 Diabetes Mellitus

German English

Eligibility

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI 2011AA
CL425202
age at least 18 Years
Description

Age at least 18 Years

Data type

boolean

Alias
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
Has type 2 diabetes and at least 18 years of age at screening.
Description

Has type 2 diabetes and at least 18 years of age at screening.

Data type

boolean

Alias
UMLS CUI 2011AA
C0011860
SNOMED CT 2011_0131
44054006
MedDRA 14.1
10012613
ICD-10-CM Version 2010
E08-E13
UMLS CUI 2011AA
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
UMLS CUI 2011AA
C1409616
Hemoglobin A1c (HbA1c) of 7.1% to 11.0%, inclusive, at screening.
Description

Hemoglobin A1c (HbA1c) of 7.1% to 11.0%, inclusive, at screening.

Data type

boolean

Alias
UMLS CUI 2011AA
C0019018
SNOMED CT 2011_0131
33601001
LOINC Version 232
MTHU018890
UMLS CUI 2011AA
C0332257
SNOMED CT 2011_0131
55919000
UMLS CUI 2011AA
C1409616
Body mass index (BMI) of 25 kg/m2 to 45 kg/m2, inclusive, at screening.
Description

Body mass index (BMI) of 25 kg/m2 to 45 kg/m2, inclusive, at screening.

Data type

boolean

Alias
UMLS CUI 2011AA
C1305855
SNOMED CT 2011_0131
140075008
MedDRA 14.1
10005894
LOINC Version 232
LP35925-4
UMLS CUI 2011AA
C0332257
SNOMED CT 2011_0131
55919000
UMLS CUI 2011AA
C1409616
Have a history of stable body weight (not varying by >5% for at least 3 months prior to screening).
Description

Have a history of stable body weight (not varying by >5% for at least 3 months prior to screening).

Data type

boolean

Alias
UMLS CUI 2011AA
CL421546
SNOMED CT 2011_0131
392521001
UMLS CUI 2011AA
C0205360
SNOMED CT 2011_0131
58158008
LOINC Version 232
MTHU015276
UMLS CUI 2011AA
C0005910
SNOMED CT 2011_0131
27113001
LOINC Version 232
MTHU001885
UMLS CUI 2011AA
C0205419
SNOMED CT 2011_0131
40885006
UMLS CUI 2011AA
C0205451
SNOMED CT 2011_0131
34001005
UMLS CUI 2011AA
C0439165
SNOMED CT 2011_0131
118582008
UMLS CUI 2011AA
C2825406
UMLS CUI 2011AA
C0439234
SNOMED CT 2011_0131
258707000
HL7 V3 2006_05
Y
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C1409616
Have been treated with metformin(Met) for at least 3 months and have been taking a stable dose for at least 8 weeks prior to screening OR
Description

Have been treated with metformin(Met) for at least 3 months and have been taking a stable dose for at least 8 weeks prior to screening OR

Data type

boolean

Alias
UMLS CUI 2011AA
CL415147
UMLS CUI 2011AA
C0025598
SNOMED CT 2011_0131
372567009
LOINC Version 232
MTHU016062
UMLS CUI 2011AA
C2825406
UMLS CUI 2011AA
C0439234
SNOMED CT 2011_0131
258707000
UMLS CUI 2011AA
C1512806
UMLS CUI 2011AA
C0205360
SNOMED CT 2011_0131
58158008
LOINC Version 232
MTHU015276
UMLS CUI 2011AA
C0178602
SNOMED CT 2011_0131
260911001
UMLS CUI 2011AA
C0205448
SNOMED CT 2011_0131
19338005
UMLS CUI 2011AA
C0439231
SNOMED CT 2011_0131
258706009
HL7 V3 2006_05
MO
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C1409616
Have been treated with metformin(Met) for at least 3 months and have been taking a stable dose for at least 8 weeks prior to screening and have been treated with SU for at least 3 months and have been taking a stable dose of at least an optimally effective dose of brand of SU for 8 weeks prior to screening.
Description

Have been treated with metformin(Met) for at least 3 months and have been taking a stable dose for at least 8 weeks prior to screening and have been treated with SU for at least 3 months and have been taking a stable dose of at least an optimally effective dose of brand of SU for 8 weeks prior to screening.

Data type

boolean

Alias
UMLS CUI 2011AA
CL415147
UMLS CUI 2011AA
C0025598
SNOMED CT 2011_0131
372567009
LOINC Version 232
MTHU016062
UMLS CUI 2011AA
C2825406
UMLS CUI 2011AA
C0439234
SNOMED CT 2011_0131
258707000
UMLS CUI 2011AA
C1512806
UMLS CUI 2011AA
C0205360
SNOMED CT 2011_0131
58158008
LOINC Version 232
MTHU015276
UMLS CUI 2011AA
C0178602
SNOMED CT 2011_0131
260911001
UMLS CUI 2011AA
C0205448
SNOMED CT 2011_0131
19338005
UMLS CUI 2011AA
C0439231
SNOMED CT 2011_0131
258706009
HL7 V3 2006_05
MO
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C1409616
UMLS CUI 2011AA
CL415147
UMLS CUI 2011AA
C0038766
UMLS CUI 2011AA
C2825406
UMLS CUI 2011AA
C0439234
SNOMED CT 2011_0131
258707000
UMLS CUI 2011AA
C1512806
UMLS CUI 2011AA
C0205360
SNOMED CT 2011_0131
58158008
LOINC Version 232
MTHU015276
UMLS CUI 2011AA
C0178602
SNOMED CT 2011_0131
260911001
UMLS CUI 2011AA
C2698651
UMLS CUI 2011AA
C0178602
SNOMED CT 2011_0131
260911001
UMLS CUI 2011AA
C0332307
SNOMED CT 2011_0131
410657003
LOINC Version 232
MTHU013727
UMLS CUI 2011AA
C0038766
UMLS CUI 2011AA
C0205448
SNOMED CT 2011_0131
19338005
UMLS CUI 2011AA
C0439231
SNOMED CT 2011_0131
258706009
HL7 V3 2006_05
MO
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C1409616
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI 2011AA
CL425201
Have had a clinically significant history of cardiac disease or presence of active cardiac disease within the year prior to inclusion in the study, including myocardial infarction, clinically significant arrhythmia, unstable angina, moderate to severe congestive heart failure, coronary artery bypass surgery, or angioplasty. or is expected to require coronary artery bypass surgery or angioplasty during the course of the study.
Description

Have had a clinically significant history of cardiac disease or presence of active cardiac disease within the year prior to inclusion in the study, including myocardial infarction, clinically significant arrhythmia, unstable angina, moderate to severe congestive heart failure, coronary artery bypass surgery, or angioplasty. or is expected to require coronary artery bypass surgery or angioplasty during the course of the study.

Data type

boolean

Alias
UMLS CUI 2011AA
C0205210
SNOMED CT 2011_0131
58147004
UMLS CUI 2011AA
C2347946
UMLS CUI 2011AA
CL421546
SNOMED CT 2011_0131
392521001
UMLS CUI 2011AA
C0018799
SNOMED CT 2011_0131
56265001
MedDRA 14.1
10061024
UMLS CUI 2011AA
CL414906
UMLS CUI 2011AA
C0205177
SNOMED CT 2011_0131
55561003
UMLS CUI 2011AA
C0018799
SNOMED CT 2011_0131
56265001
MedDRA 14.1
10061024
UMLS CUI 2011AA
C0439234
SNOMED CT 2011_0131
258707000
HL7 V3 2006_05
Y
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C0679823
HL7 V3 2006_05
PART
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
UMLS CUI 2011AA
C0332257
SNOMED CT 2011_0131
55919000
UMLS CUI 2011AA
C0027051
SNOMED CT 2011_0131
22298006
MedDRA 14.1
10028596
LOINC Version 232
MTHU035551
ICD-10-CM Version 2010
I21-I22
ICD-9-CM Version 2011
410
CTCAE 1105E
E10152
UMLS CUI 2011AA
C0205210
SNOMED CT 2011_0131
58147004
UMLS CUI 2011AA
C0750502
SNOMED CT 2011_0131
386134007
UMLS CUI 2011AA
C0003811
SNOMED CT 2011_0131
44808001
MedDRA 14.1
10003119
ICD-9-CM Version 2011
427.9
UMLS CUI 2011AA
C0002965
SNOMED CT 2011_0131
4557003
MedDRA 14.1
10002388
ICD-10-CM Version 2010
I20.0
ICD-9-CM Version 2011
411.1
UMLS CUI 2011AA
C1881878
UMLS CUI 2011AA
C0205082
SNOMED CT 2011_0131
24484000
UMLS CUI 2011AA
C0018802
SNOMED CT 2011_0131
42343007
MedDRA 14.1
10007559
LOINC Version 232
MTHU020787
ICD-10-CM Version 2010
I50.9
ICD-9-CM Version 2011
428.0
UMLS CUI 2011AA
C0010055
SNOMED CT 2011_0131
232717009
MedDRA 14.1
10011077
ICD-9-CM Version 2011
36.10
UMLS CUI 2011AA
C0162577
SNOMED CT 2011_0131
418285008
MedDRA 14.1
10002475
LOINC Version 232
MTHU011020
UMLS CUI 2011AA
CL414906
UMLS CUI 2011AA
C1517001
UMLS CUI 2011AA
C1514873
UMLS CUI 2011AA
C0010055
SNOMED CT 2011_0131
232717009
MedDRA 14.1
10011077
ICD-9-CM Version 2011
36.10
UMLS CUI 2011AA
C0162577
SNOMED CT 2011_0131
418285008
MedDRA 14.1
10002475
LOINC Version 232
MTHU011020
UMLS CUI 2011AA
C0347984
SNOMED CT 2011_0131
371881003
UMLS CUI 2011AA
C0750729
SNOMED CT 2011_0131
288524001
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
Have clinical signs or symptoms of liver disease, acute or chronic hepatitis.
Description

Have clinical signs or symptoms of liver disease, acute or chronic hepatitis.

Data type

boolean

Alias
UMLS CUI 2011AA
C0205210
SNOMED CT 2011_0131
58147004
UMLS CUI 2011AA
C0220912
UMLS CUI 2011AA
C1457887
LOINC Version 232
MTHU021540
ICD-9-CM Version 2011
780-789.99
UMLS CUI 2011AA
C0023895
SNOMED CT 2011_0131
235856003
MedDRA 14.1
10024670
ICD-10-CM Version 2010
K76.9
ICD-9-CM Version 2011
573.9
UMLS CUI 2011AA
C0267797
SNOMED CT 2011_0131
37871000
MedDRA 14.1
10019727
ICD-10-CM Version 2010
B17.9
UMLS CUI 2011AA
C0019189
SNOMED CT 2011_0131
76783007
MedDRA 14.1
10008909
ICD-10-CM Version 2010
K73.9
ICD-9-CM Version 2011
571.40
Have a history of renal transplantation or are currently receiving renal dialysis.
Description

Have a history of renal transplantation or are currently receiving renal dialysis.

Data type

boolean

Alias
UMLS CUI 2011AA
C2348568
Have active or untreated malignancy, or have been in remission from clinically significant malignancy (other than basal cell or squamous cell skin cancer, in situ carcinomas of the cervix, or in situ prostate cancer) for less than 5 years.
Description

Have active or untreated malignancy, or have been in remission from clinically significant malignancy (other than basal cell or squamous cell skin cancer, in situ carcinomas of the cervix, or in situ prostate cancer) for less than 5 years.

Data type

boolean

Alias
UMLS CUI 2011AA
C0205177
SNOMED CT 2011_0131
55561003
UMLS CUI 2011AA
C1518422
UMLS CUI 2011AA
CL415147
UMLS CUI 2011AA
C0006826
SNOMED CT 2011_0131
363346000
MedDRA 14.1
10028997
LOINC Version 232
MTHU010328
ICD-10-CM Version 2010
C00-C96
UMLS CUI 2011AA
CL414906
UMLS CUI 2011AA
C0544452
SNOMED CT 2011_0131
277022003
UMLS CUI 2011AA
C0205210
SNOMED CT 2011_0131
58147004
UMLS CUI 2011AA
C0750502
SNOMED CT 2011_0131
386134007
UMLS CUI 2011AA
C0006826
SNOMED CT 2011_0131
363346000
MedDRA 14.1
10028997
LOINC Version 232
MTHU010328
ICD-10-CM Version 2010
C00-C96
UMLS CUI 2011AA
CL411789
UMLS CUI 2011AA
C0007117
SNOMED CT 2011_0131
1338007
MedDRA 14.1
10004146
UMLS CUI 2011AA
C0553723
SNOMED CT 2011_0131
254651007
MedDRA 14.1
10041834
UMLS CUI 2011AA
C0851140
SNOMED CT 2011_0131
92564006
MedDRA 14.1
10061809
ICD-10-CM Version 2010
D06.9
ICD-9-CM Version 2011
233.1
UMLS CUI 2011AA
C0154088
SNOMED CT 2011_0131
92691004
MedDRA 14.1
10036912
ICD-10-CM Version 2010
D07.5
ICD-9-CM Version 2011
233.4
UMLS CUI 2011AA
C0547044
SNOMED CT 2011_0131
263796003
UMLS CUI 2011AA
C0205451
SNOMED CT 2011_0131
34001005
UMLS CUI 2011AA
C0439234
SNOMED CT 2011_0131
258707000
HL7 V3 2006_05
Y
Have had > 3 episodes of major hypoglycemia within 6 months prior to screening.
Description

Have had > 3 episodes of major hypoglycemia within 6 months prior to screening.

Data type

boolean

Alias
UMLS CUI 2011AA
C0332189
SNOMED CT 2011_0131
272128006
UMLS CUI 2011AA
C0205164
SNOMED CT 2011_0131
255603008
UMLS CUI 2011AA
C0020615
SNOMED CT 2011_0131
302866003
MedDRA 14.1
10020993
ICD-10-CM Version 2010
E16.2
ICD-9-CM Version 2011
251.2
CTCAE 1105E
E12322
UMLS CUI 2011AA
C2825407
UMLS CUI 2011AA
C0439234
SNOMED CT 2011_0131
258707000
HL7 V3 2006_05
Y
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C1409616
Have any contraindication for the oral antidiabetic agent which they use.
Description

Have any contraindication for the oral antidiabetic agent which they use.

Data type

boolean

Alias
UMLS CUI 2011AA
C1301624
SNOMED CT 2011_0131
397745006
UMLS CUI 2011AA
C1527415
SNOMED CT 2011_0131
26643006
HL7 V3 2006_05
_OralRoute
UMLS CUI 2011AA
C0935929
SNOMED CT 2011_0131
373245004
UMLS CUI 2011AA
C1524063
SNOMED CT 2011_0131
260676000
Have a known allergy or hypersensitivity to insulin glargine, exenatide once weekly, or excipients contained in these agents.
Description

Have a known allergy or hypersensitivity to insulin glargine, exenatide once weekly, or excipients contained in these agents.

Data type

boolean

Alias
UMLS CUI 2011AA
C0205309
SNOMED CT 2011_0131
36692007
UMLS CUI 2011AA
C0020517
SNOMED CT 2011_0131
257550005
ICD-10-CM Version 2010
T78.40
UMLS CUI 2011AA
C0907402
SNOMED CT 2011_0131
411529005
UMLS CUI 2011AA
C0167117
SNOMED CT 2011_0131
416859008
UMLS CUI 2011AA
C0558293
SNOMED CT 2011_0131
225769003
UMLS CUI 2011AA
C0015237
SNOMED CT 2011_0131
360215002
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C1254351
Are known to have active proliferative retinopathy.
Description

Are known to have active proliferative retinopathy.

Data type

boolean

Alias
UMLS CUI 2011AA
C0205309
SNOMED CT 2011_0131
36692007
UMLS CUI 2011AA
C0205177
SNOMED CT 2011_0131
55561003
UMLS CUI 2011AA
C0339467
MedDRA 14.1
10038934
Have been treated with drugs that promote weight loss (e.g., Xenical [orlistat], Meridia [sibutramine], Acomplia [rimonabant], Acutrim [phenylpropanolamine], or similar over-the-counter medications) within 3 months of screening.
Description

Have been treated with drugs that promote weight loss (e.g., Xenical [orlistat], Meridia [sibutramine], Acomplia [rimonabant], Acutrim [phenylpropanolamine], or similar over-the-counter medications) within 3 months of screening.

Data type

boolean

Alias
UMLS CUI 2011AA
CL415147
UMLS CUI 2011AA
C1254351
UMLS CUI 2011AA
C0033414
MedDRA 14.1
10036891
UMLS CUI 2011AA
C1262477
SNOMED CT 2011_0131
89362005
MedDRA 14.1
10047895
LOINC Version 232
MTHU020881
ICD-9-CM Version 2011
783.21
CTCAE 1105E
E12228
UMLS CUI 2011AA
C0732649
SNOMED CT 2011_0131
387007000
UMLS CUI 2011AA
C0074493
SNOMED CT 2011_0131
386838007
LOINC Version 232
MTHU035870
UMLS CUI 2011AA
C1142933
SNOMED CT 2011_0131
422794008
UMLS CUI 2011AA
C0031495
SNOMED CT 2011_0131
387464001
LOINC Version 232
MTHU005032
UMLS CUI 2011AA
C2348205
UMLS CUI 2011AA
C0013231
SNOMED CT 2011_0131
329505003, 80288002
UMLS CUI 2011AA
C0332285
SNOMED CT 2011_0131
18720000
UMLS CUI 2011AA
C2825406
UMLS CUI 2011AA
C0439234
SNOMED CT 2011_0131
258707000
HL7 V3 2006_05
Y
UMLS CUI 2011AA
C1409616
Have been treated for longer than 2 weeks with any of the following excluded medications within 3 months prior to screening:
Description

Have been treated for longer than 2 weeks with any of the following excluded medications within 3 months prior to screening:

Data type

boolean

Alias
UMLS CUI 2011AA
CL415147
UMLS CUI 2011AA
C0205172
SNOMED CT 2011_0131
242762006
UMLS CUI 2011AA
C0205448
SNOMED CT 2011_0131
19338005
UMLS CUI 2011AA
C0439230
SNOMED CT 2011_0131
258705008
HL7 V3 2006_05
WK
UMLS CUI 2011AA
C0332282
SNOMED CT 2011_0131
255260001
UMLS CUI 2011AA
CL411789
UMLS CUI 2011AA
C0013227
UMLS CUI 2011AA
C2825406
UMLS CUI 2011AA
C0439234
SNOMED CT 2011_0131
258707000
HL7 V3 2006_05
Y
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C1409616
Insulin, regular insulin
Description

Insulin

Data type

boolean

Alias
UMLS CUI 2011AA
C0021641
SNOMED CT 2011_0131
67866001
LOINC Version 232
MTHU019392
Thiazolidinediones (e.g., Actos [pioglitazone] or Avandia [rosiglitazone])
Description

Thiazolidinediones (e.g., Actos [pioglitazone] or Avandia [rosiglitazone])

Data type

boolean

Alpha-glucosidase inhibitors (e.g., Glyset [miglitol] or Precose [acarbose])
Description

Alpha-glucosidase inhibitors (e.g., Glyset [miglitol] or Precose [acarbose])

Data type

boolean

Alias
UMLS CUI 2011AA
C2267008
UMLS CUI 2011AA
C0066535
SNOMED CT 2011_0131
109071007
UMLS CUI 2011AA
C0591572
SNOMED CT 2011_0131
386965004
Meglitinides (e.g., Prandin [repaglinide] or Starlix [nateglinide]).
Description

Meglitinides (e.g., Prandin [repaglinide] or Starlix [nateglinide]).

Data type

boolean

Alias
UMLS CUI 2011AA
C1579432
UMLS CUI 2011AA
C0246689
SNOMED CT 2011_0131
386964000
LOINC Version 232
MTHU017515
UMLS CUI 2011AA
C1323198
SNOMED CT 2011_0131
387070004
LOINC Version 232
MTHU026435
Byetta (exenatide BID formulation)
Description

Byetta (exenatide BID formulation)

Data type

boolean

Alias
UMLS CUI 2011AA
C0167117
SNOMED CT 2011_0131
416859008
UMLS CUI 2011AA
C0585361
SNOMED CT 2011_0131
229799001
HL7 V3 2006_05
BID
UMLS CUI 2011AA
C0524527
Dipeptidyl peptidase (DPP)-4 inhibitors (e.g., Januvia [sitagliptin], Galvus [vildagliptin])
Description

Dipeptidyl peptidase (DPP)-4 inhibitors (e.g., Januvia [sitagliptin], Galvus [vildagliptin])

Data type

boolean

Alias
UMLS CUI 2011AA
C1827106
SNOMED CT 2011_0131
423837000
UMLS CUI 2011AA
C1702177
UMLS CUI 2011AA
C1565750
SNOMED CT 2011_0131
423307000
UMLS CUI 2011AA
C1721378
UMLS CUI 2011AA
C1570906
SNOMED CT 2011_0131
428611002
Symlin, Pramlintide Acetate
Description

Symlin (pramlintide acetate).

Data type

boolean

Alias
UMLS CUI 2011AA
C1174780
SNOMED CT 2011_0131
427360000
Organ Transplantation, Organ Transplant
Description

Have had an organ transplant.

Data type

boolean

Alias
UMLS CUI 2011AA
C0029216
MedDRA 14.1
10061890
LOINC Version 232
MTHU000173
Have donated blood within 30 days of screening.
Description

Have donated blood within 30 days of screening.

Data type

boolean

Alias
UMLS CUI 2011AA
C0005794
SNOMED CT 2011_0131
25179006
UMLS CUI 2011AA
C0332285
SNOMED CT 2011_0131
18720000
UMLS CUI 2011AA
C0439231
SNOMED CT 2011_0131
258706009
HL7 V3 2006_05
MO
UMLS CUI 2011AA
C1409616
Have previously completed or withdrawn from this study or any other study investigating exenatide once weekly.
Description

Have previously completed or withdrawn from this study or any other study investigating exenatide once weekly.

Data type

boolean

Alias
UMLS CUI 2011AA
C0205156
SNOMED CT 2011_0131
9130008
UMLS CUI 2011AA
C1556116
HL7 V3 2006_05
completed
UMLS CUI 2011AA
C0422727
SNOMED CT 2011_0131
185924006
UMLS CUI 2011AA
C0205394
SNOMED CT 2011_0131
74964007
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
UMLS CUI 2011AA
C0430007
UMLS CUI 2011AA
C0167117
SNOMED CT 2011_0131
416859008
UMLS CUI 2011AA
C0558293
SNOMED CT 2011_0131
225769003
Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry.
Description

Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry.

Data type

boolean

Alias
UMLS CUI 2011AA
C1514756
UMLS CUI 2011AA
C0039798
UMLS CUI 2011AA
C0332285
SNOMED CT 2011_0131
18720000
UMLS CUI 2011AA
C1517741
UMLS CUI 2011AA
C0439231
SNOMED CT 2011_0131
258706009
HL7 V3 2006_05
MO
UMLS CUI 2011AA
C1254351
UMLS CUI 2011AA
C1518422
UMLS CUI 2011AA
C1514756
UMLS CUI 2011AA
C1704735
UMLS CUI 2011AA
C0205540
SNOMED CT 2011_0131
9571008
UMLS CUI 2011AA
CL335836
UMLS CUI 2011AA
C2348558
Are currently enrolled in any other clinical study.
Description

Are currently enrolled in any other clinical study.

Data type

boolean

Alias
UMLS CUI 2011AA
C0521116
SNOMED CT 2011_0131
15240007
UMLS CUI 2011AA
C1516879
UMLS CUI 2011AA
C0205394
SNOMED CT 2011_0131
74964007
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
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Similar models

Eligibility

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Inclusion Criteria
CL425202 (UMLS CUI 2011AA)
Age at least 18 Years
Item
age at least 18 Years
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
Has type 2 diabetes and at least 18 years of age at screening.
Item
Has type 2 diabetes and at least 18 years of age at screening.
boolean
C0011860 (UMLS CUI 2011AA)
44054006 (SNOMED CT 2011_0131)
10012613 (MedDRA 14.1)
E08-E13 (ICD-10-CM Version 2010)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C1409616 (UMLS CUI 2011AA)
Hemoglobin A1c (HbA1c) of 7.1% to 11.0%, inclusive, at screening.
Item
Hemoglobin A1c (HbA1c) of 7.1% to 11.0%, inclusive, at screening.
boolean
C0019018 (UMLS CUI 2011AA)
33601001 (SNOMED CT 2011_0131)
MTHU018890 (LOINC Version 232)
C0332257 (UMLS CUI 2011AA)
55919000 (SNOMED CT 2011_0131)
C1409616 (UMLS CUI 2011AA)
Body mass index (BMI) of 25 kg/m2 to 45 kg/m2, inclusive, at screening.
Item
Body mass index (BMI) of 25 kg/m2 to 45 kg/m2, inclusive, at screening.
boolean
C1305855 (UMLS CUI 2011AA)
140075008 (SNOMED CT 2011_0131)
10005894 (MedDRA 14.1)
LP35925-4 (LOINC Version 232)
C0332257 (UMLS CUI 2011AA)
55919000 (SNOMED CT 2011_0131)
C1409616 (UMLS CUI 2011AA)
Have a history of stable body weight (not varying by >5% for at least 3 months prior to screening).
Item
Have a history of stable body weight (not varying by >5% for at least 3 months prior to screening).
boolean
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0205360 (UMLS CUI 2011AA)
58158008 (SNOMED CT 2011_0131)
MTHU015276 (LOINC Version 232)
C0005910 (UMLS CUI 2011AA)
27113001 (SNOMED CT 2011_0131)
MTHU001885 (LOINC Version 232)
C0205419 (UMLS CUI 2011AA)
40885006 (SNOMED CT 2011_0131)
C0205451 (UMLS CUI 2011AA)
34001005 (SNOMED CT 2011_0131)
C0439165 (UMLS CUI 2011AA)
118582008 (SNOMED CT 2011_0131)
C2825406 (UMLS CUI 2011AA)
C0439234 (UMLS CUI 2011AA)
258707000 (SNOMED CT 2011_0131)
Y (HL7 V3 2006_05)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C1409616 (UMLS CUI 2011AA)
Have been treated with metformin(Met) for at least 3 months and have been taking a stable dose for at least 8 weeks prior to screening OR
Item
Have been treated with metformin(Met) for at least 3 months and have been taking a stable dose for at least 8 weeks prior to screening OR
boolean
CL415147 (UMLS CUI 2011AA)
C0025598 (UMLS CUI 2011AA)
372567009 (SNOMED CT 2011_0131)
MTHU016062 (LOINC Version 232)
C2825406 (UMLS CUI 2011AA)
C0439234 (UMLS CUI 2011AA)
258707000 (SNOMED CT 2011_0131)
C1512806 (UMLS CUI 2011AA)
C0205360 (UMLS CUI 2011AA)
58158008 (SNOMED CT 2011_0131)
MTHU015276 (LOINC Version 232)
C0178602 (UMLS CUI 2011AA)
260911001 (SNOMED CT 2011_0131)
C0205448 (UMLS CUI 2011AA)
19338005 (SNOMED CT 2011_0131)
C0439231 (UMLS CUI 2011AA)
258706009 (SNOMED CT 2011_0131)
MO (HL7 V3 2006_05)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C1409616 (UMLS CUI 2011AA)
Have been treated with metformin(Met) for at least 3 months and have been taking a stable dose for at least 8 weeks prior to screening and have been treated with SU for at least 3 months and have been taking a stable dose of at least an optimally effective dose of brand of SU for 8 weeks prior to screening.
Item
Have been treated with metformin(Met) for at least 3 months and have been taking a stable dose for at least 8 weeks prior to screening and have been treated with SU for at least 3 months and have been taking a stable dose of at least an optimally effective dose of brand of SU for 8 weeks prior to screening.
boolean
CL415147 (UMLS CUI 2011AA)
C0025598 (UMLS CUI 2011AA)
372567009 (SNOMED CT 2011_0131)
MTHU016062 (LOINC Version 232)
C2825406 (UMLS CUI 2011AA)
C0439234 (UMLS CUI 2011AA)
258707000 (SNOMED CT 2011_0131)
C1512806 (UMLS CUI 2011AA)
C0205360 (UMLS CUI 2011AA)
58158008 (SNOMED CT 2011_0131)
MTHU015276 (LOINC Version 232)
C0178602 (UMLS CUI 2011AA)
260911001 (SNOMED CT 2011_0131)
C0205448 (UMLS CUI 2011AA)
19338005 (SNOMED CT 2011_0131)
C0439231 (UMLS CUI 2011AA)
258706009 (SNOMED CT 2011_0131)
MO (HL7 V3 2006_05)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C1409616 (UMLS CUI 2011AA)
CL415147 (UMLS CUI 2011AA)
C0038766 (UMLS CUI 2011AA)
C2825406 (UMLS CUI 2011AA)
C0439234 (UMLS CUI 2011AA)
258707000 (SNOMED CT 2011_0131)
C1512806 (UMLS CUI 2011AA)
C0205360 (UMLS CUI 2011AA)
58158008 (SNOMED CT 2011_0131)
MTHU015276 (LOINC Version 232)
C0178602 (UMLS CUI 2011AA)
260911001 (SNOMED CT 2011_0131)
C2698651 (UMLS CUI 2011AA)
C0178602 (UMLS CUI 2011AA)
260911001 (SNOMED CT 2011_0131)
C0332307 (UMLS CUI 2011AA)
410657003 (SNOMED CT 2011_0131)
MTHU013727 (LOINC Version 232)
C0038766 (UMLS CUI 2011AA)
C0205448 (UMLS CUI 2011AA)
19338005 (SNOMED CT 2011_0131)
C0439231 (UMLS CUI 2011AA)
258706009 (SNOMED CT 2011_0131)
MO (HL7 V3 2006_05)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C1409616 (UMLS CUI 2011AA)
Item Group
Exclusion Criteria
CL425201 (UMLS CUI 2011AA)
Have had a clinically significant history of cardiac disease or presence of active cardiac disease within the year prior to inclusion in the study, including myocardial infarction, clinically significant arrhythmia, unstable angina, moderate to severe congestive heart failure, coronary artery bypass surgery, or angioplasty. or is expected to require coronary artery bypass surgery or angioplasty during the course of the study.
Item
Have had a clinically significant history of cardiac disease or presence of active cardiac disease within the year prior to inclusion in the study, including myocardial infarction, clinically significant arrhythmia, unstable angina, moderate to severe congestive heart failure, coronary artery bypass surgery, or angioplasty. or is expected to require coronary artery bypass surgery or angioplasty during the course of the study.
boolean
C0205210 (UMLS CUI 2011AA)
58147004 (SNOMED CT 2011_0131)
C2347946 (UMLS CUI 2011AA)
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0018799 (UMLS CUI 2011AA)
56265001 (SNOMED CT 2011_0131)
10061024 (MedDRA 14.1)
CL414906 (UMLS CUI 2011AA)
C0205177 (UMLS CUI 2011AA)
55561003 (SNOMED CT 2011_0131)
C0018799 (UMLS CUI 2011AA)
56265001 (SNOMED CT 2011_0131)
10061024 (MedDRA 14.1)
C0439234 (UMLS CUI 2011AA)
258707000 (SNOMED CT 2011_0131)
Y (HL7 V3 2006_05)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C0679823 (UMLS CUI 2011AA)
PART (HL7 V3 2006_05)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C0332257 (UMLS CUI 2011AA)
55919000 (SNOMED CT 2011_0131)
C0027051 (UMLS CUI 2011AA)
22298006 (SNOMED CT 2011_0131)
10028596 (MedDRA 14.1)
MTHU035551 (LOINC Version 232)
I21-I22 (ICD-10-CM Version 2010)
410 (ICD-9-CM Version 2011)
E10152 (CTCAE 1105E)
C0205210 (UMLS CUI 2011AA)
58147004 (SNOMED CT 2011_0131)
C0750502 (UMLS CUI 2011AA)
386134007 (SNOMED CT 2011_0131)
C0003811 (UMLS CUI 2011AA)
44808001 (SNOMED CT 2011_0131)
10003119 (MedDRA 14.1)
427.9 (ICD-9-CM Version 2011)
C0002965 (UMLS CUI 2011AA)
4557003 (SNOMED CT 2011_0131)
10002388 (MedDRA 14.1)
I20.0 (ICD-10-CM Version 2010)
411.1 (ICD-9-CM Version 2011)
C1881878 (UMLS CUI 2011AA)
C0205082 (UMLS CUI 2011AA)
24484000 (SNOMED CT 2011_0131)
C0018802 (UMLS CUI 2011AA)
42343007 (SNOMED CT 2011_0131)
10007559 (MedDRA 14.1)
MTHU020787 (LOINC Version 232)
I50.9 (ICD-10-CM Version 2010)
428.0 (ICD-9-CM Version 2011)
C0010055 (UMLS CUI 2011AA)
232717009 (SNOMED CT 2011_0131)
10011077 (MedDRA 14.1)
36.10 (ICD-9-CM Version 2011)
C0162577 (UMLS CUI 2011AA)
418285008 (SNOMED CT 2011_0131)
10002475 (MedDRA 14.1)
MTHU011020 (LOINC Version 232)
CL414906 (UMLS CUI 2011AA)
C1517001 (UMLS CUI 2011AA)
C1514873 (UMLS CUI 2011AA)
C0010055 (UMLS CUI 2011AA)
232717009 (SNOMED CT 2011_0131)
10011077 (MedDRA 14.1)
36.10 (ICD-9-CM Version 2011)
C0162577 (UMLS CUI 2011AA)
418285008 (SNOMED CT 2011_0131)
10002475 (MedDRA 14.1)
MTHU011020 (LOINC Version 232)
C0347984 (UMLS CUI 2011AA)
371881003 (SNOMED CT 2011_0131)
C0750729 (UMLS CUI 2011AA)
288524001 (SNOMED CT 2011_0131)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
Have clinical signs or symptoms of liver disease, acute or chronic hepatitis.
Item
Have clinical signs or symptoms of liver disease, acute or chronic hepatitis.
boolean
C0205210 (UMLS CUI 2011AA)
58147004 (SNOMED CT 2011_0131)
C0220912 (UMLS CUI 2011AA)
C1457887 (UMLS CUI 2011AA)
MTHU021540 (LOINC Version 232)
780-789.99 (ICD-9-CM Version 2011)
C0023895 (UMLS CUI 2011AA)
235856003 (SNOMED CT 2011_0131)
10024670 (MedDRA 14.1)
K76.9 (ICD-10-CM Version 2010)
573.9 (ICD-9-CM Version 2011)
C0267797 (UMLS CUI 2011AA)
37871000 (SNOMED CT 2011_0131)
10019727 (MedDRA 14.1)
B17.9 (ICD-10-CM Version 2010)
C0019189 (UMLS CUI 2011AA)
76783007 (SNOMED CT 2011_0131)
10008909 (MedDRA 14.1)
K73.9 (ICD-10-CM Version 2010)
571.40 (ICD-9-CM Version 2011)
Have a history of renal transplantation or are currently receiving renal dialysis.
Item
Have a history of renal transplantation or are currently receiving renal dialysis.
boolean
C2348568 (UMLS CUI 2011AA)
Have active or untreated malignancy, or have been in remission from clinically significant malignancy (other than basal cell or squamous cell skin cancer, in situ carcinomas of the cervix, or in situ prostate cancer) for less than 5 years.
Item
Have active or untreated malignancy, or have been in remission from clinically significant malignancy (other than basal cell or squamous cell skin cancer, in situ carcinomas of the cervix, or in situ prostate cancer) for less than 5 years.
boolean
C0205177 (UMLS CUI 2011AA)
55561003 (SNOMED CT 2011_0131)
C1518422 (UMLS CUI 2011AA)
CL415147 (UMLS CUI 2011AA)
C0006826 (UMLS CUI 2011AA)
363346000 (SNOMED CT 2011_0131)
10028997 (MedDRA 14.1)
MTHU010328 (LOINC Version 232)
C00-C96 (ICD-10-CM Version 2010)
CL414906 (UMLS CUI 2011AA)
C0544452 (UMLS CUI 2011AA)
277022003 (SNOMED CT 2011_0131)
C0205210 (UMLS CUI 2011AA)
58147004 (SNOMED CT 2011_0131)
C0750502 (UMLS CUI 2011AA)
386134007 (SNOMED CT 2011_0131)
C0006826 (UMLS CUI 2011AA)
363346000 (SNOMED CT 2011_0131)
10028997 (MedDRA 14.1)
MTHU010328 (LOINC Version 232)
C00-C96 (ICD-10-CM Version 2010)
CL411789 (UMLS CUI 2011AA)
C0007117 (UMLS CUI 2011AA)
1338007 (SNOMED CT 2011_0131)
10004146 (MedDRA 14.1)
C0553723 (UMLS CUI 2011AA)
254651007 (SNOMED CT 2011_0131)
10041834 (MedDRA 14.1)
C0851140 (UMLS CUI 2011AA)
92564006 (SNOMED CT 2011_0131)
10061809 (MedDRA 14.1)
D06.9 (ICD-10-CM Version 2010)
233.1 (ICD-9-CM Version 2011)
C0154088 (UMLS CUI 2011AA)
92691004 (SNOMED CT 2011_0131)
10036912 (MedDRA 14.1)
D07.5 (ICD-10-CM Version 2010)
233.4 (ICD-9-CM Version 2011)
C0547044 (UMLS CUI 2011AA)
263796003 (SNOMED CT 2011_0131)
C0205451 (UMLS CUI 2011AA)
34001005 (SNOMED CT 2011_0131)
C0439234 (UMLS CUI 2011AA)
258707000 (SNOMED CT 2011_0131)
Y (HL7 V3 2006_05)
Have had > 3 episodes of major hypoglycemia within 6 months prior to screening.
Item
Have had > 3 episodes of major hypoglycemia within 6 months prior to screening.
boolean
C0332189 (UMLS CUI 2011AA)
272128006 (SNOMED CT 2011_0131)
C0205164 (UMLS CUI 2011AA)
255603008 (SNOMED CT 2011_0131)
C0020615 (UMLS CUI 2011AA)
302866003 (SNOMED CT 2011_0131)
10020993 (MedDRA 14.1)
E16.2 (ICD-10-CM Version 2010)
251.2 (ICD-9-CM Version 2011)
E12322 (CTCAE 1105E)
C2825407 (UMLS CUI 2011AA)
C0439234 (UMLS CUI 2011AA)
258707000 (SNOMED CT 2011_0131)
Y (HL7 V3 2006_05)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C1409616 (UMLS CUI 2011AA)
Have any contraindication for the oral antidiabetic agent which they use.
Item
Have any contraindication for the oral antidiabetic agent which they use.
boolean
C1301624 (UMLS CUI 2011AA)
397745006 (SNOMED CT 2011_0131)
C1527415 (UMLS CUI 2011AA)
26643006 (SNOMED CT 2011_0131)
_OralRoute (HL7 V3 2006_05)
C0935929 (UMLS CUI 2011AA)
373245004 (SNOMED CT 2011_0131)
C1524063 (UMLS CUI 2011AA)
260676000 (SNOMED CT 2011_0131)
Have a known allergy or hypersensitivity to insulin glargine, exenatide once weekly, or excipients contained in these agents.
Item
Have a known allergy or hypersensitivity to insulin glargine, exenatide once weekly, or excipients contained in these agents.
boolean
C0205309 (UMLS CUI 2011AA)
36692007 (SNOMED CT 2011_0131)
C0020517 (UMLS CUI 2011AA)
257550005 (SNOMED CT 2011_0131)
T78.40 (ICD-10-CM Version 2010)
C0907402 (UMLS CUI 2011AA)
411529005 (SNOMED CT 2011_0131)
C0167117 (UMLS CUI 2011AA)
416859008 (SNOMED CT 2011_0131)
C0558293 (UMLS CUI 2011AA)
225769003 (SNOMED CT 2011_0131)
C0015237 (UMLS CUI 2011AA)
360215002 (SNOMED CT 2011_0131)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C1254351 (UMLS CUI 2011AA)
Are known to have active proliferative retinopathy.
Item
Are known to have active proliferative retinopathy.
boolean
C0205309 (UMLS CUI 2011AA)
36692007 (SNOMED CT 2011_0131)
C0205177 (UMLS CUI 2011AA)
55561003 (SNOMED CT 2011_0131)
C0339467 (UMLS CUI 2011AA)
10038934 (MedDRA 14.1)
Have been treated with drugs that promote weight loss (e.g., Xenical [orlistat], Meridia [sibutramine], Acomplia [rimonabant], Acutrim [phenylpropanolamine], or similar over-the-counter medications) within 3 months of screening.
Item
Have been treated with drugs that promote weight loss (e.g., Xenical [orlistat], Meridia [sibutramine], Acomplia [rimonabant], Acutrim [phenylpropanolamine], or similar over-the-counter medications) within 3 months of screening.
boolean
CL415147 (UMLS CUI 2011AA)
C1254351 (UMLS CUI 2011AA)
C0033414 (UMLS CUI 2011AA)
10036891 (MedDRA 14.1)
C1262477 (UMLS CUI 2011AA)
89362005 (SNOMED CT 2011_0131)
10047895 (MedDRA 14.1)
MTHU020881 (LOINC Version 232)
783.21 (ICD-9-CM Version 2011)
E12228 (CTCAE 1105E)
C0732649 (UMLS CUI 2011AA)
387007000 (SNOMED CT 2011_0131)
C0074493 (UMLS CUI 2011AA)
386838007 (SNOMED CT 2011_0131)
MTHU035870 (LOINC Version 232)
C1142933 (UMLS CUI 2011AA)
422794008 (SNOMED CT 2011_0131)
C0031495 (UMLS CUI 2011AA)
387464001 (SNOMED CT 2011_0131)
MTHU005032 (LOINC Version 232)
C2348205 (UMLS CUI 2011AA)
C0013231 (UMLS CUI 2011AA)
329505003, 80288002 (SNOMED CT 2011_0131)
C0332285 (UMLS CUI 2011AA)
18720000 (SNOMED CT 2011_0131)
C2825406 (UMLS CUI 2011AA)
C0439234 (UMLS CUI 2011AA)
258707000 (SNOMED CT 2011_0131)
Y (HL7 V3 2006_05)
C1409616 (UMLS CUI 2011AA)
Have been treated for longer than 2 weeks with any of the following excluded medications within 3 months prior to screening:
Item
Have been treated for longer than 2 weeks with any of the following excluded medications within 3 months prior to screening:
boolean
CL415147 (UMLS CUI 2011AA)
C0205172 (UMLS CUI 2011AA)
242762006 (SNOMED CT 2011_0131)
C0205448 (UMLS CUI 2011AA)
19338005 (SNOMED CT 2011_0131)
C0439230 (UMLS CUI 2011AA)
258705008 (SNOMED CT 2011_0131)
WK (HL7 V3 2006_05)
C0332282 (UMLS CUI 2011AA)
255260001 (SNOMED CT 2011_0131)
CL411789 (UMLS CUI 2011AA)
C0013227 (UMLS CUI 2011AA)
C2825406 (UMLS CUI 2011AA)
C0439234 (UMLS CUI 2011AA)
258707000 (SNOMED CT 2011_0131)
Y (HL7 V3 2006_05)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C1409616 (UMLS CUI 2011AA)
Insulin
Item
Insulin, regular insulin
boolean
C0021641 (UMLS CUI 2011AA)
67866001 (SNOMED CT 2011_0131)
MTHU019392 (LOINC Version 232)
Thiazolidinediones (e.g., Actos [pioglitazone] or Avandia [rosiglitazone])
Item
Thiazolidinediones (e.g., Actos [pioglitazone] or Avandia [rosiglitazone])
boolean
Alpha-glucosidase inhibitors (e.g., Glyset [miglitol] or Precose [acarbose])
Item
Alpha-glucosidase inhibitors (e.g., Glyset [miglitol] or Precose [acarbose])
boolean
C2267008 (UMLS CUI 2011AA)
C0066535 (UMLS CUI 2011AA)
109071007 (SNOMED CT 2011_0131)
C0591572 (UMLS CUI 2011AA)
386965004 (SNOMED CT 2011_0131)
Meglitinides (e.g., Prandin [repaglinide] or Starlix [nateglinide]).
Item
Meglitinides (e.g., Prandin [repaglinide] or Starlix [nateglinide]).
boolean
C1579432 (UMLS CUI 2011AA)
C0246689 (UMLS CUI 2011AA)
386964000 (SNOMED CT 2011_0131)
MTHU017515 (LOINC Version 232)
C1323198 (UMLS CUI 2011AA)
387070004 (SNOMED CT 2011_0131)
MTHU026435 (LOINC Version 232)
Byetta (exenatide BID formulation)
Item
Byetta (exenatide BID formulation)
boolean
C0167117 (UMLS CUI 2011AA)
416859008 (SNOMED CT 2011_0131)
C0585361 (UMLS CUI 2011AA)
229799001 (SNOMED CT 2011_0131)
BID (HL7 V3 2006_05)
C0524527 (UMLS CUI 2011AA)
Dipeptidyl peptidase (DPP)-4 inhibitors (e.g., Januvia [sitagliptin], Galvus [vildagliptin])
Item
Dipeptidyl peptidase (DPP)-4 inhibitors (e.g., Januvia [sitagliptin], Galvus [vildagliptin])
boolean
C1827106 (UMLS CUI 2011AA)
423837000 (SNOMED CT 2011_0131)
C1702177 (UMLS CUI 2011AA)
C1565750 (UMLS CUI 2011AA)
423307000 (SNOMED CT 2011_0131)
C1721378 (UMLS CUI 2011AA)
C1570906 (UMLS CUI 2011AA)
428611002 (SNOMED CT 2011_0131)
Symlin (pramlintide acetate).
Item
Symlin, Pramlintide Acetate
boolean
C1174780 (UMLS CUI 2011AA)
427360000 (SNOMED CT 2011_0131)
Have had an organ transplant.
Item
Organ Transplantation, Organ Transplant
boolean
C0029216 (UMLS CUI 2011AA)
10061890 (MedDRA 14.1)
MTHU000173 (LOINC Version 232)
Have donated blood within 30 days of screening.
Item
Have donated blood within 30 days of screening.
boolean
C0005794 (UMLS CUI 2011AA)
25179006 (SNOMED CT 2011_0131)
C0332285 (UMLS CUI 2011AA)
18720000 (SNOMED CT 2011_0131)
C0439231 (UMLS CUI 2011AA)
258706009 (SNOMED CT 2011_0131)
MO (HL7 V3 2006_05)
C1409616 (UMLS CUI 2011AA)
Have previously completed or withdrawn from this study or any other study investigating exenatide once weekly.
Item
Have previously completed or withdrawn from this study or any other study investigating exenatide once weekly.
boolean
C0205156 (UMLS CUI 2011AA)
9130008 (SNOMED CT 2011_0131)
C1556116 (UMLS CUI 2011AA)
completed (HL7 V3 2006_05)
C0422727 (UMLS CUI 2011AA)
185924006 (SNOMED CT 2011_0131)
C0205394 (UMLS CUI 2011AA)
74964007 (SNOMED CT 2011_0131)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C0430007 (UMLS CUI 2011AA)
C0167117 (UMLS CUI 2011AA)
416859008 (SNOMED CT 2011_0131)
C0558293 (UMLS CUI 2011AA)
225769003 (SNOMED CT 2011_0131)
Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry.
Item
Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry.
boolean
C1514756 (UMLS CUI 2011AA)
C0039798 (UMLS CUI 2011AA)
C0332285 (UMLS CUI 2011AA)
18720000 (SNOMED CT 2011_0131)
C1517741 (UMLS CUI 2011AA)
C0439231 (UMLS CUI 2011AA)
258706009 (SNOMED CT 2011_0131)
MO (HL7 V3 2006_05)
C1254351 (UMLS CUI 2011AA)
C1518422 (UMLS CUI 2011AA)
C1514756 (UMLS CUI 2011AA)
C1704735 (UMLS CUI 2011AA)
C0205540 (UMLS CUI 2011AA)
9571008 (SNOMED CT 2011_0131)
CL335836 (UMLS CUI 2011AA)
C2348558 (UMLS CUI 2011AA)
Are currently enrolled in any other clinical study.
Item
Are currently enrolled in any other clinical study.
boolean
C0521116 (UMLS CUI 2011AA)
15240007 (SNOMED CT 2011_0131)
C1516879 (UMLS CUI 2011AA)
C0205394 (UMLS CUI 2011AA)
74964007 (SNOMED CT 2011_0131)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
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